Exact FDA event identifier

Event 85125

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 02, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Mayne Pharma Inc

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01

D-0998-2020

Recall number: D-0998-2020
Initiated: March 02, 2020
Classification: Class II
Status: Terminated
Recalling firm: Mayne Pharma Inc
Quantity: 8274 100-count bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

foreign tablet

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product Mix-Up: A foreign tablet was found in bottle.

Code information

Lot: FG11514 Exp. 05/2021

Distribution pattern

Distributed Nationwide in the USA